Clinical Investigation
Interventional Cardiology
A propensity analysis of the risk of vascular complications after cardiac catheterization procedures with the use of vascular closure devices

https://doi.org/10.1016/j.ahj.2006.12.014Get rights and content

Background

Complications of vascular access are one of the most common adverse events after coronary angiography and percutaneous coronary intervention (PCI) and are reported to occur in 1% to 9% of cases. There are conflicting reports of the association of vascular complications with the use of vascular closure devices (VCDs). The purpose of this study was to assess femoral arterial access–related vascular outcomes after invasive cardiology procedures with the routine use of VCDs.

Methods

A total of 12 937 consecutive patients were studied for inhospital outcomes through a prospective registry from January 2002 to December 2005. Of these, 6913 (53%) patients underwent PCI and 9996 (77%) patients received VCDs. Univariate and multivariate logistic regression analyses were used to determine the predictors of vascular complications. A propensity analysis of VCD use was performed to account for potential bias in the likelihood of using such devices.

Results

Vascular complications occurred in 0.7% of diagnostic angiography and 2.7% of PCI patients. The risk of vascular complications was significantly lower with closure device use compared with manual compression in both diagnostic angiography (0.5% vs 1.1%, P = .01*) and PCI (2.4% vs 4.9%, P < .001*) groups. Multivariate logistic regression analysis, after accounting for the propensity to use such devices, revealed that VCD use was associated with a 58% (95% CI 19%-88%) reduction in the risk of vascular complications in diagnostic procedures catheterization and a 42% (95% CI 17%-59%) reduction in PCI patients.

Conclusions

In contemporary practice, VCDs offer reduced risk of vascular complications as compared with manual compression in appropriately selected patients undergoing diagnostic and therapeutic cardiac catheterizations.

Section snippets

Methods

We prospectively evaluated consecutive patients undergoing cardiac catheterization and PCIs via femoral access at the Brigham and Women's Hospital between January 1, 2002, and December 31, 2005, for the occurrence of inhospital vascular complications. A prospective catheterization laboratory database, based on the American College of Cardiology–National Cardiovascular Data Registry definitions, was used to record clinical and procedural elements for each case.23 Only patients presenting in

Results

Table I describes the baseline characteristics of the 12 937 study patients, of which 6024 (47%) underwent diagnostic coronary catheterization and 6913 (53%) underwent PCI. Vascular closure devices were used for hemostasis in 9996 cases (77%). Collagen-based Angio-Seal device was used in 8201 (82%), suture-based Perclose device in 1691 (17%), and other VCDs in 104 (1%) cases, respectively. Sixty-seven percent of the patients in diagnostic catheterization and 86% of those in the PCI group

Discussion

The present study describes femoral arterial access site complications and impact of VCDs in >12 000 consecutive patients treated during the contemporary era of diagnostic cardiac catheterization and PCI. The risk of vascular complications was 0.7% in the diagnostic group and 2.7% in PCI patients, which is comparable with previously published literature.1, 5, 6, 7, 8 In this study, the most powerful predictor of complications in both diagnostic and therapeutic groups is nonuse of VCDs. For

References (31)

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This study was supported, in part, by grants R01-LM08142 (NA and FSR) and 1-T15-LM-07092 (MEM) from the National Library of Medicine of the National Institutes of Health, USA. In addition, the study was supported, in part, by an unrestricted educational grant from St Jude Medical.

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